Canadian consumers are no doubt familiar with the straightforward “Talk to Your Doctor” message of pharmaceutical advertisements in Canada, often accompanied by images of ordinary Canadians and a brand name or logo of a drug but with no mention of the disease it treats. Take, for example, the advertisement “Good Morning” that aired a few years back in which a man is shown happily heading off to work. The ad closes with the VIAGRA logo and the words “Talk to Your Doctor”. While such ads typically promote brand awareness and not much more, this is not simply a marketing strategy on the part of Canadian drug companies.
In fact, the Food and Drugs Act (FDA) and its regulations restrictively govern what pharmaceutical companies can include in their advertisements in Canada. As one would expect, a drug cannot be advertised in manner that is false, misleading, deceptive or likely to create an erroneous impression of the drug’s character, value, quantity, composition, merit or safety. Going beyond that are provisions that reflect Health Canada’s long-standing policy against direct-to-consumer pharmaceutical advertising and to encourage individuals to seek the advice of health care professionals and/or practitioners for treatment of serious diseases.
Key prohibitions are:
- Advertising any prescription drug to the general public containing any representation other than the brand name, proper name, common name, price and quantity of the drug. The associated disease cannot be mentioned.
- Advertising any drug to the general public with a claim that the drug treats, prevents or cures any one of a number of specific diseases (“Schedule A diseases” – see below). A “preventative” claim includes risk reduction and “treatment” includes symptomatic treatment.
While Health Canada’s policy has not changed, as of June 1, 2008, the restrictions have loosened somewhat as a result of statutory and regulatory amendments that took effect on that date that are part of an ongoing effort to modernize the regulation of health products.
Schedule A, which was added to the FDA in 1934, has been updated to list diseases, disorders or abnormal physical states that meet defined criteria. Generally speaking, these are the diseases that Health Canada considers to be life-threatening or acute forms of specific diseases, such as cancer, gangrene and obesity. Conditions that are not considered acutely serious (such as sexual impotence and dysentery) have been removed and others have been narrowed (e.g., liver disease has been changed to hepatitis).
In addition, changes to the Food and Drug Regulations and the Natural Health Products Regulations have exempted most non-prescription drugs and all natural health products from the general prohibition in the FDA against preventative claims for Schedule A diseases. Manufacturers of non-prescription drugs and products such as herbal remedies and probiotics are now able to advertise and label their products using preventative claims, provided such claims are first approved by Health Canada.
Additional changes could be on the way that may further loosen the restrictions imposed upon pharmaceutical companies. This past spring, the government tabled Bill C-51. If passed, the Bill would amend the FDA and other related laws and may result in a restructuring of the current regulatory regime and may allow direct-to-consumer advertising of pharmaceutical products. Whether Bill C-51 will pass remains to be seen, as does the resulting impact on the advertising of pharmaceutical products in Canada.